Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China

ISRCTN	ISRCTN08850194
DOI	https://doi.org/10.1186/ISRCTN08850194
Secondary identifying numbers	YH101-H12/03

Submission date: 17/11/2006
Registration date: 14/12/2006
Last edited: 19/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Hong Yan
Scientific

No 76 Western Yanta Road
Xi'an
710061
China

Phone	+86 (0)29 8265 5001
Email	yanhonge@mail.xjtu.edu.cn

Study information

Study design	Grouped randomised double-blind controlled community trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Impact of iron/folate versus multi-micronutrient supplementation during pregnancy on birth weight: a randomised controlled trial in rural Western China
Study hypothesis	1. The newborn infants of women receiving the multi-micronutrient supplements will at least experience a 50% reduction in prevalence of low birth weight (less than 2500 g) in comparison those receiving folate alone. 2. The newborn infants of women receiving the iron/folate supplements will at least experience a 25% reduction in the prevalence of low birth weight (less than 2500 g) in comparison those receiving folate alone 3. The women receiving the multi-micronutrient supplements in comparison those receiving iron/folate supplements, will at least experience a 30% reduction in the prevalence of anemia (Haemoglobin [Hb] less than 11 g/dL) in the third trimester (30 to 32 weeks of gestation).
Ethics approval(s)	Committee for Science and Research at the Xi'an Jiaotong University, 10/04/2002, ref: 2002002
Condition	Low birth weight; preterm delivery; anaemia
Intervention	Hamlets were randomly assigned for women to receive one of the following three daily antenatal supplements: 1. Multi-micronutrients 2. Iron and folic acid 3. Folic acid alone (control) The multi-micronutrient supplements were formuated to contain the Required Dietary Allowances (RDA) for each of the micronutrients and if taken throughout pregnancy should provide a sufficient intake of each micronutrient to correct any underlying deficiencies (30 mg iron, 400 µg folate, 15.0 mg zinc, 2.0 mg copper, 65.0 µg selenium, 150.0 µg iodine, 800.0 µg vitamin A, 1.4 mg Vitamin B1, 1.4 mg vitamin B2, 1.9 mg vitamin B6, 2.6 µg vitamin B12, 5.0 µg vitamin D, 70.0 mg vitamin C, 10.0 mg vitamin E, and 18.0 mg Niacin). The iron/folate supplements contained 60 mg of iron and 400 µg of folic acid. The folate-only supplement contained 400 µg of folic acid. These supplements were identical in appearance and participants, investigators, field staff, and statisticians did nor know supplement codes until the study finished.
Intervention type	Supplement
Primary outcome measure	1. Duration of pregnancy 2. Birth weight, length and head circumference 3. Haemoglobin level of pregnant women at the start of their third trimester
Secondary outcome measures	1. Compliance with supplements 2. Side effects of supplements 3. Complications of pregnancy: 3.1. Hypertension and preeclampsia 3.2. Antepartum haemorrhage 3.3. Infections 4. Type of delivery and type of assistance 5. Delivery complications: 5.1. Prolonged labour 5.2. Postpartum haemorrhage 5.3. Duration of maternal hospital admission 6. Early neonatal morbidity
Overall study start date	01/08/2002
Overall study end date	24/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	7144 eligible pregnant women
Total final enrolment	5828
Participant inclusion criteria	Women invited to participate in the trial must be less than 28 weeks of gestation
Participant exclusion criteria	Women will be excluded from the trial if already taking iron, folate, and other micronutrients supplements for more than two weeks
Recruitment start date	01/08/2002
Recruitment end date	24/01/2006

Locations

Countries of recruitment

China

Study participating centre

No 76 Western Yanta Road

Xi'an
710061
China

Sponsor information

United Nations Children's Fund (UNICEF) (China)
Research organisation

c/o Lilian Selenje
Health and Nutrition
12 Sanlitun Lu
Beijing
100600
China

Website	http://www.unicef.org/china/index.html
"ROR"	https://ror.org/02dg0pv02

Funders

Funder type

Research organisation

UNICEF (Project No.: YH101-H12/03)
Government organisation / International organizations

Alternative name(s): United Nations Children's Fund, United Nations Children's Emergency Fund, Fonds des Nations Unies pour l'enfance, Fondo de las Naciones Unidas para la Infancia, صندوق الأمم المتحدة للطفولة, 联合国儿童基金会
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/11/2008		Yes	No
Results article	results	09/07/2009		Yes	No
Results article	30-month follow-up results	01/02/2012		Yes	No
Results article	results	01/08/2015		Yes	No
Results article	results	01/11/2016		Yes	No
Results article	results	01/09/2018		Yes	No
Results article	results	01/06/2020	12/08/2019	Yes	No
Results article	14-year follow-up	07/12/2022	19/12/2022	Yes	No

Editorial Notes

19/12/2022: Publication reference added.
12/08/2019: Publication reference and total final enrolment added.
11/07/2018: Publication reference added.
28/07/2016: Publication reference added.